DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 Aug 2026, to include the claim amendment filed 11 Aug 2026, has been entered.
Claims 1 and 3-6 are pending in the application with claims 7-8 canceled. Claims 1 and 4-6 are currently amended. Applicant’s amendment to the Claims have overcome each and every objection and 35 U.S.C. 112 rejection previously set forth in the Final Office Action mailed 24 Jul 2026.
It is noted that upon reconsideration the limitation “fine particle generating element” in claim 3 is no longer interpreted as invoking 35 U.S.C. 112(f) as that terminology would reasonably convey particular structure options to one of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed 11 Aug 2026 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 103 of claim 1 applicant argues the particular placement of the drug fine particle generator within the apparatus is not taught or suggested by the prior art of record (Pg. 4-10).
On Pg. 7 applicant discusses the benefits of the instantly claimed configuration and alleges the configuration as reducing the risk of leakage or contamination as compared with Fig. 1 of Montgomery. That argument is not found convincing since Montgomery discusses in ¶0027 that the “the nebulizer is sealed in the airway” which indicates the leakage would not be a particular concern in Montgomery.
Applicant’s arguments continue on Pg. 7 to discuss an alleged benefit over Montgomery as providing an inner portion of the medication case which may be fundamentally blocked from being exposed. It is respectfully submitted that the cover and the medication case are only recited in claim 3 and that claim 3 was already previously indicated as allowable over Montgomery (see Pg. 16 of the Final Office action mailed 24 Jul 2026).
On Pg. 8 applicant traverses the obviousness statement of the Final Office action regarding the placement of the T-tube as connected to the Y-tube. Applicant’s main argument is asserting the benefit of the instantly disclosed configuration (Pg. 8-10). Applicant asserts the claimed configuration is not merely a simple arrangement or change of position, but a technical means by which the inventor is solving a particular problem (Pg. 8).
While the technical benefit arrived at by the inventor is appreciated the question of obviousness itself has not been directly addressed in applicant’s remarks. Applicant has only asserted the benefits of the instant invention while not addressing why such a configuration would not have been obvious when beginning from Montgomery. It is respectfully submitted that Montgomery teaches both 1) preferentially locating the nebulizer proximate to the patient near the wye piece (¶0028) and 2) preferably locating the nebulizer near the distal end of the inspiratory tubing (¶0026). Those two teachings would have been considered as obviously suggestive to one of ordinary skill in the art attempting to place the nebulizer as close to the wye piece as possible, to include as directly connected with each other. Applicant’s arguments regarding the 35 U.S.C. 103 rejection of claim 1 are thus not found persuasive.
Claim Objections
Claim(s) 6 is/are objected to because of the following informalities:
Claim 6, Ln. 24 recites “the mask or the mouthpiece” which should read “a mask or a mouthpiece” as it is a first introduction
Claim 6, Ln. 25 recites “the inhaled by” which should read “the inhaled air by”
Claim 6, Ln. 30 recites “a mask or a mouthpiece” following after Ln. 24 of the claim
Appropriate correction is required.
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “heating and humidifying apparatus being configured to generate second air by adjusting a temperature and a humidity of the first air” in claims 1 and 4-6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for the heating and humidifying apparatus is best understood from the specification as at least: heating and humidifying apparatus 3 in the form of a heating humidifier common in the art (e.g. Fig. 1).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery (U.S. Pub. 2013/0014759) in view of Smaldone (U.S. Pub. 2021/0236750) and further in view of Parker et al. (U.S. Pub. 2007/0157931).
Regarding claim 1, Montgomery discloses an aerosol drug supply apparatus (Fig. 1; ¶0025) for a respirator (¶0025), the aerosol drug supply apparatus comprising: an air purifier (Fig. 1 #1; ¶0025) configured to discharge first air in which an oxygen concentration, a pressure, and a speed thereof are set (¶0028 – delivered air has some oxygen in it, positive pressure, air has some flow rate); a first tube (Fig. 1 between #1 and #4) along which the first air moves; a humidifying apparatus (Fig. 1 #4; ¶0025) connected to the first tube, the humidifying apparatus being configured to generate second air by a humidity of the first air (¶¶0025, 0037), and the humidifying apparatus being configured to discharge the second air; a second tube (Fig. 1 between #4 and #5) which is connected to the humidifying apparatus and along which the second air moves; a T-tube (Fig. 1 at #5) having a straight tube (Fig. 1 inline with inspiration flow) that has one side thereof provided with a branch tube (Fig. 1 to which nebulizer 5 is attached; ¶¶0025, 0036), the straight tube being directly connected to the second tube (Fig. 1), thereby allowing the second air to pass therethrough; a drug fine particle generator (Fig. 1 #5; ¶¶0025, 0036) mounted on the branch tube, and the drug fine particle generator being configured to spray a drug in a fine particle state to the second air (¶¶0035-0037); a Y-tube (Fig. 1 connecting inspiratory limb and expiratory limb to #6), the Y-tube having another side connected to a mask or a mouthpiece (¶0038 – endotracheal tubing is readable on a mouthpiece); and a return tube (Fig. 1 #3; ¶0025) having one side connected to the Y-tube (Fig. 1), the return tube having another side connected to the air purifier (Fig. 1), thereby allowing exhaled air to flow therethrough. It is noted that the “air purifier” is not expressly recited as either including any structure which performs purifying or as functionally performing any purifying of air. Thus, the term “purifier” is only understood as intended functionality and is given limited patentable weight (see MPEP 2114).
Montgomery fails to disclose an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air and being configured to generate a sensing signal based on the first air; the drug fine particle generator being configured to be operated only when the sensing signal is input to the drug fine particle generator. Montgomery fails to explicitly disclose the humidifying apparatus also performs heating; and the Y-tube having one side directly connected to the T-tube.
The illustration of Fig. 1 of Montgomery shows an additional piece of tubing between in-line nebulizer 5 and the wye piece, which means they are not necessarily “connected” in the illustration. However, Montgomery teaches it is preferred to locate the nebulizer proximate to the patient near the wye piece (¶0028). Montgomery also teaches the nebulizer as preferably near the distal end of the inspiratory tubing (¶0026). One of ordinary skill in the art would thus have considered it prima facie obvious to have specified in Montgomery the in-line nebulizer 5 as connected to the wye piece as fulfilling a preferred intention of Montgomery to locate the nebulizer as close to the patient as possible while still maintaining the nebulizer in a position upstream of the wye piece (e.g. ¶0028 and Fig. 1).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the Y-tube having one side directly connected to the T-tube in order to provide the benefit of locate the drug fine particle generator (i.e. the nebulizer of Montgomery) as close to the patient as possible while still maintaining the drug fine particle generator in a position upstream of the Y-tube in view of the preference of this type of positioning as taught by Montgomery.
Smaldone teaches a ventilator circuit including a nebulizer (e.g. Figs. 1 & 5; ¶¶0034, 0048) including an inhaled air sensor (Figs. 1 & 5 #114; ¶0037) connected to a ventilator (Figs. 1 & 5 #102; ¶0037), the inhaled air sensor being configured to sense air exiting the ventilator and to generate a sensing signal (¶0037); and a nebulizer (Figs. 1 & 5 #101; ¶0037) being configured to be operated only when the sensing signal is input (¶0037 – nebulizer turned off when inhalation phase no longer detected). Smaldone teaches an inhaled air sensor controlling operation of a nebulizer as providing the benefit of synchronizing nebulizer delivery to only occur upon breath-actuation (¶¶0037-0039). It is additionally noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Montgomery an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air and being configured to generate a sensing signal based on the first air; the drug fine particle generator being configured to be operated only when the sensing signal is input to the drug fine particle generator in order to provide the benefit of controlling operation of the drug fine particle generator (i.e. the nebulizer of Montgomery) to only delivery nebulized drug upon breath-actuation in view of Smaldone. It is again noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
Parker teaches a ventilator circuit including a nebulizer (Fig. 2; ¶¶0077, 0080) and teaches the circuit used with a humidifier obviously controlled to provide heating to its humidified air (¶0170 – different temperatures of gases delivered). One of ordinary skill in the art would have obviously recognized that heating is a common function of humidifiers in the respiratory art as heating of the humidified gas helps ensure patient comfort by providing the humidified gas close to a normal physiological temperature.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the humidifying apparatus also performs heating in order to provide the benefit of heating the humidified air to help ensure patient comfort by providing the humidified air close to a normal physiological temperature both in view of Parker and the common use of humidifiers in the respiratory art.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery (U.S. Pub. 2013/0014759) in view of Smaldone (U.S. Pub. 2021/0236750) and further in view of Parker et al. (U.S. Pub. 2007/0157931) and further in view of Porter et al. (U.S. Pub. 2018/0272081).
Regarding claim 4, Montgomery discloses an aerosol drug supply apparatus (Fig. 1; ¶0025) for a respirator (¶0025), the aerosol drug supply apparatus comprising: an air purifier (Fig. 1 #1; ¶0025) configured to discharge first air in which an oxygen concentration, a pressure, and a speed thereof are set (¶0028 – delivered air has some oxygen in it, positive pressure, air has some flow rate); a first tube (Fig. 1 between #1 and #4) along which the first air moves; a humidifying apparatus (Fig. 1 #4; ¶0025) connected to the first tube, the humidifying apparatus being configured to generate second air by a humidity of the first air (¶¶0025, 0037), and the humidifying apparatus being configured to discharge the second air; a second tube (Fig. 1 between #4 and #5) which is connected to the humidifying apparatus and along which the second air moves; a T-tube (Fig. 1 at #5) having a straight tube (Fig. 1 inline with inspiration flow) that has one side thereof provided with a branch tube (Fig. 1 to which nebulizer 5 is attached; ¶¶0025, 0036), the straight tube being directly connected to the second tube (Fig. 1), thereby allowing the second air to pass therethrough; a drug fine particle generator (Fig. 1 #5; ¶¶0025, 0036) mounted on the branch tube, and the drug fine particle generator being configured to spray a drug in a fine particle state to the second air (¶¶0035-0037); a Y-tube (Fig. 1 connecting inspiratory limb and expiratory limb to #6), the Y-tube having another side connected to a mask or a mouthpiece (¶0038 – endotracheal tubing is readable on a mouthpiece); and a return tube (Fig. 1 #3; ¶0025) having one side connected to the Y-tube (Fig. 1), the return tube having another side connected to the air purifier (Fig. 1), thereby allowing exhaled air to flow therethrough. It is noted that the “air purifier” is not expressly recited as either including any structure which performs purifying or as functionally performing any purifying of air. Thus, the term “purifier” is only understood as intended functionality and is given limited patentable weight (see MPEP 2114).
Montgomery fails to disclose an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air; a sensing signal is a signal generated by a chest sensor, configured to be mounted on a patient's chest, and wherein the chest sensor is configured to detect when the patient's chest expands; the drug fine particle generator being configured to be operated only when the sensing signal is input to the drug fine particle generator. Montgomery fails to explicitly disclose the humidifying apparatus also performs heating; and the Y-tube having one side directly connected to the T-tube.
The illustration of Fig. 1 of Montgomery shows an additional piece of tubing between in-line nebulizer 5 and the wye piece, which means they are not necessarily “connected” in the illustration. However, Montgomery teaches it is preferred to locate the nebulizer proximate to the patient near the wye piece (¶0028). Montgomery also teaches the nebulizer as preferably near the distal end of the inspiratory tubing (¶0026). One of ordinary skill in the art would thus have considered it prima facie obvious to have specified in Montgomery the in-line nebulizer 5 as connected to the wye piece as fulfilling a preferred intention of Montgomery to locate the nebulizer as close to the patient as possible while still maintaining the nebulizer in a position upstream of the wye piece (e.g. ¶0028 and Fig. 1).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the Y-tube having one side directly connected to the T-tube in order to provide the benefit of locate the drug fine particle generator (i.e. the nebulizer of Montgomery) as close to the patient as possible while still maintaining the drug fine particle generator in a position upstream of the Y-tube in view of the preference of this type of positioning as taught by Montgomery.
Smaldone teaches a ventilator circuit including a nebulizer (e.g. Figs. 1 & 5; ¶¶0034, 0048) including an inhaled air sensor (Figs. 1 & 5 #114; ¶0037) connected to a ventilator (Figs. 1 & 5 #102; ¶0037), the inhaled air sensor being configured to sense air exiting the ventilator and to generate a sensing signal (¶0037); and a nebulizer (Figs. 1 & 5 #101; ¶0037) being configured to be operated only when the sensing signal is input (¶0037 – nebulizer turned off when inhalation phase no longer detected). Smaldone teaches an inhaled air sensor controlling operation of a nebulizer as providing the benefit of synchronizing nebulizer delivery to only occur upon breath-actuation (¶¶0037-0039). It is additionally noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Montgomery an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air in order to provide the benefit of controlling operation of the drug fine particle generator (i.e. the nebulizer of Montgomery) to only delivery nebulized drug upon breath-actuation in view of Smaldone. It is again noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
Parker teaches a ventilator circuit including a nebulizer (Fig. 2; ¶¶0077, 0080) and teaches the circuit used with a humidifier obviously controlled to provide heating to its humidified air (¶0170 – different temperatures of gases delivered). One of ordinary skill in the art would have obviously recognized that heating is a common function of humidifiers in the respiratory art as heating of the humidified gas helps ensure patient comfort by providing the humidified gas close to a normal physiological temperature.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the humidifying apparatus also performs heating in order to provide the benefit of heating the humidified air to help ensure patient comfort by providing the humidified air close to a normal physiological temperature both in view of Parker and the common use of humidifiers in the respiratory art.
Porter teaches an aerosol delivery system (Fig. 2; ¶0031) including breath sensors (Fig. 2 #34; ¶0033) to control aerosol delivery based on a patient’s breath cycle (¶0033) which can take various forms, to include an impedance plethysmography sensor (Fig. 3 #40; ¶0035). One of ordinary skill in the art would recognize the impedance plethysmography sensor 40 of Fig. 3 as being a chest sensor which detects when the patient's chest expands. Porter thus teaches a chest sensor as an obvious design choice option of a breath sensor known in the art to be usable for controlling aerosol delivery based on a patient’s breath cycle.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have further incorporated in Montgomery a sensing signal is a signal generated by a chest sensor, configured to be mounted on a patient's chest, and wherein the chest sensor is configured to detect when the patient's chest expands; the drug fine particle generator being configured to be operated only when the sensing signal is input to the drug fine particle generator in order to provide the benefit of adding an additional form of breath sensor known in the art to be usable for controlling aerosol delivery based on a patient’s breath cycle in view of Porter. It is again noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery (U.S. Pub. 2013/0014759) in view of Smaldone (U.S. Pub. 2021/0236750) and further in view of Parker et al. (U.S. Pub. 2007/0157931) and further in view of Spandorfer (U.S. Pub. 2016/0136368).
Regarding claim 5, Montgomery discloses an aerosol drug supply apparatus (Fig. 1; ¶0025) for a respirator (¶0025), the aerosol drug supply apparatus comprising: an air purifier (Fig. 1 #1; ¶0025) configured to discharge first air in which an oxygen concentration, a pressure, and a speed thereof are set (¶0028 – delivered air has some oxygen in it, positive pressure, air has some flow rate); a first tube (Fig. 1 between #1 and #4) along which the first air moves; a humidifying apparatus (Fig. 1 #4; ¶0025) connected to the first tube, the humidifying apparatus being configured to generate second air by a humidity of the first air (¶¶0025, 0037), and the humidifying apparatus being configured to discharge the second air; a second tube (Fig. 1 between #4 and #5) which is connected to the humidifying apparatus and along which the second air moves; a T-tube (Fig. 1 at #5) having a straight tube (Fig. 1 inline with inspiration flow) that has one side thereof provided with a branch tube (Fig. 1 to which nebulizer 5 is attached; ¶¶0025, 0036), the straight tube being directly connected to the second tube (Fig. 1), thereby allowing the second air to pass therethrough; a drug fine particle generator (Fig. 1 #5; ¶¶0025, 0036) mounted on the branch tube, and the drug fine particle generator being configured to spray a drug in a fine particle state to the second air (¶¶0035-0037); a Y-tube (Fig. 1 connecting inspiratory limb and expiratory limb to #6), the Y-tube having another side connected to a mask or a mouthpiece (¶0038 – endotracheal tubing is readable on a mouthpiece); and a return tube (Fig. 1 #3; ¶0025) having one side connected to the Y-tube (Fig. 1), the return tube having another side connected to the air purifier (Fig. 1), thereby allowing exhaled air to flow therethrough. It is noted that the “air purifier” is not expressly recited as either including any structure which performs purifying or as functionally performing any purifying of air. Thus, the term “purifier” is only understood as intended functionality and is given limited patentable weight (see MPEP 2114).
Montgomery fails to disclose an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air; a sensing signal is a specific brain wave signal generated when a patient is breathing; the drug fine particle generator being configured to be operated only when the sensing signal is input to the drug fine particle generator. Montgomery fails to explicitly disclose the humidifying apparatus also performs heating; and the Y-tube having one side directly connected to the T-tube.
The illustration of Fig. 1 of Montgomery shows an additional piece of tubing between in-line nebulizer 5 and the wye piece, which means they are not necessarily “connected” in the illustration. However, Montgomery teaches it is preferred to locate the nebulizer proximate to the patient near the wye piece (¶0028). Montgomery also teaches the nebulizer as preferably near the distal end of the inspiratory tubing (¶0026). One of ordinary skill in the art would thus have considered it prima facie obvious to have specified in Montgomery the in-line nebulizer 5 as connected to the wye piece as fulfilling a preferred intention of Montgomery to locate the nebulizer as close to the patient as possible while still maintaining the nebulizer in a position upstream of the wye piece (e.g. ¶0028 and Fig. 1).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the Y-tube having one side directly connected to the T-tube in order to provide the benefit of locate the drug fine particle generator (i.e. the nebulizer of Montgomery) as close to the patient as possible while still maintaining the drug fine particle generator in a position upstream of the Y-tube in view of the preference of this type of positioning as taught by Montgomery.
Smaldone teaches a ventilator circuit including a nebulizer (e.g. Figs. 1 & 5; ¶¶0034, 0048) including an inhaled air sensor (Figs. 1 & 5 #114; ¶0037) connected to a ventilator (Figs. 1 & 5 #102; ¶0037), the inhaled air sensor being configured to sense air exiting the ventilator and to generate a sensing signal (¶0037); and a nebulizer (Figs. 1 & 5 #101; ¶0037) being configured to be operated only when the sensing signal is input (¶0037 – nebulizer turned off when inhalation phase no longer detected). Smaldone teaches an inhaled air sensor controlling operation of a nebulizer as providing the benefit of synchronizing nebulizer delivery to only occur upon breath-actuation (¶¶0037-0039). It is additionally noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Montgomery an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air in order to provide the benefit of controlling operation of the drug fine particle generator (i.e. the nebulizer of Montgomery) to only delivery nebulized drug upon breath-actuation in view of Smaldone. It is again noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
Parker teaches a ventilator circuit including a nebulizer (Fig. 2; ¶¶0077, 0080) and teaches the circuit used with a humidifier obviously controlled to provide heating to its humidified air (¶0170 – different temperatures of gases delivered). One of ordinary skill in the art would have obviously recognized that heating is a common function of humidifiers in the respiratory art as heating of the humidified gas helps ensure patient comfort by providing the humidified gas close to a normal physiological temperature.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the humidifying apparatus also performs heating in order to provide the benefit of heating the humidified air to help ensure patient comfort by providing the humidified air close to a normal physiological temperature both in view of Parker and the common use of humidifiers in the respiratory art.
Spandorfer teaches an automated aerosol drug dispensing system (Fig. 1; ¶¶0005, 0025) and teaches “smart” automated actuation of dispensing can be performed in response to a variety of patient physiological measures, to include EEG (¶0044). One of ordinary skill in the art would obviously recognize that EEG is used to monitor brain waves. Spandorfer thus teaches EEG, as a brain wave sensor, as an obvious design choice option of patient physiologic sensor known in the art to be usable for controlling automated actuation of aerosol delivery.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have further incorporated in Montgomery a sensing signal is a specific brain wave signal generated when a patient is breathing; the drug fine particle generator being configured to be operated only when the sensing signal is input to the drug fine particle generator in order to provide the benefit of adding an additional form of patient physiological measure known in the art to be usable for controlling automated actuation of aerosol delivery in view of Spandorfer. It is again noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery (U.S. Pub. 2013/0014759) in view of Smaldone (U.S. Pub. 2021/0236750) and further in view of Parker et al. (U.S. Pub. 2007/0157931) and further in view of Heinonen (U.S. Patent 6474333).
Regarding claim 6, Montgomery discloses an aerosol drug supply apparatus (Fig. 1; ¶0025) for a respirator (¶0025), the aerosol drug supply apparatus comprising: an air purifier (Fig. 1 #1; ¶0025) configured to discharge first air in which an oxygen concentration, a pressure, and a speed thereof are set (¶0028 – delivered air has some oxygen in it, positive pressure, air has some flow rate); a first tube (Fig. 1 between #1 and #4) along which the first air moves; a humidifying apparatus (Fig. 1 #4; ¶0025) connected to the first tube, the humidifying apparatus being configured to generate second air by a humidity of the first air (¶¶0025, 0037), and the humidifying apparatus being configured to discharge the second air; a second tube (Fig. 1 between #4 and #5) which is connected to the humidifying apparatus and along which the second air moves; a T-tube (Fig. 1 at #5) having a straight tube (Fig. 1 inline with inspiration flow) that has one side thereof provided with a branch tube (Fig. 1 to which nebulizer 5 is attached; ¶¶0025, 0036), the straight tube being directly connected to the second tube (Fig. 1), thereby allowing the second air to pass therethrough; a drug fine particle generator (Fig. 1 #5; ¶¶0025, 0036) mounted on the branch tube, and the drug fine particle generator being configured to spray a drug in a fine particle state to the second air (¶¶0035-0037); a Y-tube (Fig. 1 connecting inspiratory limb and expiratory limb to #6), the Y-tube having another side connected to a mask or a mouthpiece (¶0038 – endotracheal tubing is readable on a mouthpiece); and a return tube (Fig. 1 #3; ¶0025) having one side connected to the Y-tube (Fig. 1), the return tube having another side connected to the air purifier (Fig. 1), thereby allowing exhaled air to flow therethrough. It is noted that the “air purifier” is not expressly recited as either including any structure which performs purifying or as functionally performing any purifying of air. Thus, the term “purifier” is only understood as intended functionality and is given limited patentable weight (see MPEP 2114).
Montgomery fails to disclose an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air; a sensing signal is: a signal generated by detecting an air flow of inhaled air by another inhaled air sensor in a mask or a mouthpiece, a signal generated by detecting an air pressure of the inhaled by the another inhaled air sensor in the mask or the mouthpiece, or a signal generated by detecting an air temperature of the inhaled air by the another inhaled air sensor in the mask or the mouthpiece; the drug fine particle generator being configured to be operated only when the sensing signal is input to the drug fine particle generator. Montgomery fails to explicitly disclose the humidifying apparatus also performs heating; and the Y-tube having one side directly connected to the T-tube.
The illustration of Fig. 1 of Montgomery shows an additional piece of tubing between in-line nebulizer 5 and the wye piece, which means they are not necessarily “connected” in the illustration. However, Montgomery teaches it is preferred to locate the nebulizer proximate to the patient near the wye piece (¶0028). Montgomery also teaches the nebulizer as preferably near the distal end of the inspiratory tubing (¶0026). One of ordinary skill in the art would thus have considered it prima facie obvious to have specified in Montgomery the in-line nebulizer 5 as connected to the wye piece as fulfilling a preferred intention of Montgomery to locate the nebulizer as close to the patient as possible while still maintaining the nebulizer in a position upstream of the wye piece (e.g. ¶0028 and Fig. 1).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the Y-tube having one side directly connected to the T-tube in order to provide the benefit of locate the drug fine particle generator (i.e. the nebulizer of Montgomery) as close to the patient as possible while still maintaining the drug fine particle generator in a position upstream of the Y-tube in view of the preference of this type of positioning as taught by Montgomery.
Smaldone teaches a ventilator circuit including a nebulizer (e.g. Figs. 1 & 5; ¶¶0034, 0048) including an inhaled air sensor (Figs. 1 & 5 #114; ¶0037) connected to a ventilator (Figs. 1 & 5 #102; ¶0037), the inhaled air sensor being configured to sense air exiting the ventilator and to generate a sensing signal (¶0037); and a nebulizer (Figs. 1 & 5 #101; ¶0037) being configured to be operated only when the sensing signal is input (¶0037 – nebulizer turned off when inhalation phase no longer detected). Smaldone teaches an inhaled air sensor controlling operation of a nebulizer as providing the benefit of synchronizing nebulizer delivery to only occur upon breath-actuation (¶¶0037-0039). It is additionally noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Montgomery an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air in order to provide the benefit of controlling operation of the drug fine particle generator (i.e. the nebulizer of Montgomery) to only delivery nebulized drug upon breath-actuation in view of Smaldone. It is again noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
Parker teaches a ventilator circuit including a nebulizer (Fig. 2; ¶¶0077, 0080) and teaches the circuit used with a humidifier obviously controlled to provide heating to its humidified air (¶0170 – different temperatures of gases delivered). One of ordinary skill in the art would have obviously recognized that heating is a common function of humidifiers in the respiratory art as heating of the humidified gas helps ensure patient comfort by providing the humidified gas close to a normal physiological temperature.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the humidifying apparatus also performs heating in order to provide the benefit of heating the humidified air to help ensure patient comfort by providing the humidified air close to a normal physiological temperature both in view of Parker and the common use of humidifiers in the respiratory art.
Heinonen teaches a respiratory gas system (Fig. 1; Col. 4) and teaches a flow sensor (Fig. 1 #8; Col. 4, Ln. 20-21) downstream of a patient wye (Fig. 1 #7) which is used to control gas delivery to only during patient inhalation (Col. 5, Ln. 22-47 & Col. 6, Ln. 30-43 – pulsed delivery only during inhalation; see also Figs. 2A-2B). Additionally, Heinonen teaches a flow or pressure sensor can be included in a face mask for identifying distinctions between patient exhalation and inhalation (Col. 7, Ln. 31-35).
Heinonen thus teaches flow or pressure sensing as an obvious design choice option of patient physiologic sensor known in the art to be usable for controlling automated actuation of therapeutic gas delivery.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have further incorporated in Montgomery a sensing signal is: a signal generated by detecting an air flow of inhaled air by another inhaled air sensor in a mask or a mouthpiece, or a signal generated by detecting an air pressure of the inhaled by the another inhaled air sensor in the mask or the mouthpiece; the drug fine particle generator being configured to be operated only when the sensing signal is input to the drug fine particle generator in order to provide the benefit of adding an additional form of patient physiological measure known in the art to be usable for controlling automated actuation of aerosol delivery in view of Heinonen. It is again noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
Allowable Subject Matter
Claim(s) 3 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, the claim remains allowed over the prior art for the same reasons discussed in the preceding Office actions.
Conclusion
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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